Registration Dossier
Registration Dossier
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EC number: 446-650-2 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Directive 96/54/EEC, B.1tris
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Health Effects Test Guidelines, OPPTS 870.1000 Acute Toxicity Testing EPA 712-C- 98-189, August 1998.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Testing Methods for New Chemical Substances according to the Revised Japanese Chemical Substance Law (March 31, 1987).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Batch: C02421 -1620
Purity: 98.6%
Test animals
- Species:
- rat
- Strain:
- other: rat, HanBrl: Wist (SPF)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:RCC Ltd, Laboratory Animal Services CH-4414 Fullinsdorf / Switzerland
- Age at study initiation:12 weeks
- identification: Unique cage number and corresponding color-coded spots on the tail. The animals were marked at acclimatization start.
- randomization: Selected by hand at time of delivery. No computer generated randomization program.
- Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding (’Lignocel’ Schill AG, CH-4132 Muttenz Switzerland).
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 4/03 (Provimi Kliba AG, CH-4303 KaiseraugsVSwitzerland) ad libitum. Results of analyses for contaminants are archived at RCC Ltd, Itingen.
- Water (e.g. ad libitum):Community tap water from Fullinsdorf ad /jbjtum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with target ranges for room temperature 22 +/- 3 °C and for relative humidity between 30-70%. (values above 70 % during cleaning process possible), 12 hours fluorescent light/12 hours dark, music during the light period.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Three female rats received a single dose of the test item by oral gavage administration at 2000 mg/kg body weight after being fasted for approximately 18 hours (access to water was permitted). Food was provided again 3 hours after dosing.
The application volume was 10 ml/kg body weight.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- No clinical signs were observed during the course of the study.
- Body weight:
- One female animal showed a loss of body weight (0.6 %) between test day 8 and the end of the observation period. The body weight of the other animals was within the range commonly recorded for this strain and age.
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose of ucb 6474 after single oral administration to female rats, observed over a period of 14 days is: LD50 (female rat): greater than 2000 mg/kg body weight
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